NCT05977010

Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 58 (actual)
• Sponsor: Ina-Respond · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of Tangerang District Hospital. The participant will be interviewed and retrieved for their demographics, treatment history, CD4 and viral load history. Blood will be drawn for HIV-1 viral load examination using Xpert® HIV-1 Viral Load \[Cepheid\], in-house qRT-PCR, and REALTIME HIV-1 VIRAL LOAD \[Abbott\]

Detailed description

Participant candidate will be screened at Tangerang District Hospital's outpatient and inpatient units. The purpose is to get various VL values from participants with various clinical conditions (light-heavy). If a participant is willing to participate and has signed the Informed Consent Form (ICF), he/she will be interviewed for demographic data and case history (age, gender, first HIV diagnosis). After that, the participant will be physically examined (height, weight, and vital signs). Other information, such as current HIV clinical stage, current ART regimen, Viral Load value (final and highest), and CD4 (final and lowest) are collected from participant's medical records. The participant's blood will be drawn as much as 9 ml and will be processed to obtain plasma. Plasma will be aliquoted into 3 vials for VL test using 3 devices: 1 ml using Xpert HIV-1, 1 ml using PCR (Abbott) at Dharmais Hospital, and 1 ml or leftover plasma using PCR (ABI7500) at INA-RESPOND's reference laboratory. The process follows the manufacturer's manual or the standard of sample preparation procedure and the operation of the devices at each hospital. The result of viral load measurement will be informed to the participant via the attending physician during the participant's routine HIV treatment visit to the hospital.

Conditions

• HIV

Timeline

• Start date: 2018-01-08
• Primary completion: 2018-01-10
• Completion: 2018-01-15
• First posted: 2023-08-04
• Last updated: 2023-08-04

Locations

1 site across 1 country: Indonesia